CTRI/2024/05/066648尚未招募2 期
Efficacy of two different doses of Transdermal Buprenorphine Patch for Analgesia in patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia – A Randomized Controlled Trial.
Dr Katta Vani1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total doses of post-operative rescue analgesia requirement.
研究概览
简要总结
Total Knee Replacement surgery is usually done under Spinal Anaesthesia. Transdermal Buprenorphine Patch provides pain relief for longer duration which is also simple, non-invasive and compliant method of drug delivery. This will lead to early ambulation and early discharge and also have a better quality of recovery. Thus we want to compare the buprenorphine patch of 5mcg/hour with 10 mcg/hour in providing better pain relief with lesser side effects and better quality of recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia.
- •American Society Of Anesthesiologists (ASA) physical status I and II.
- •70 years of age of either gender.
排除标准
- •Allergy to Buprenorphine
- •Opioid dependency for more than 3 months
- •Alcoholic Liver Disease, Chronic Kidney Disease 4 and 5
- •Pregnant women
- •Malignancy
- •Patient on any anti-depressants (or) anti-convulsant
- •Morbidly Obese (BMI more than 35).
结局指标
主要结局
Total doses of post-operative rescue analgesia requirement.
时间窗: Up to 72 hours post-operatively.
次要结局
- 1. Pain Score by 11-Point Numerical Rating Scale (NRS) at 8th, 24th, 48th and 72nd hours post-operatively.(2. Sedation Score by Ramsay Sedation Score (RSS) at 8th, 24th, 48th and 72nd hours post-operatively.)
研究者
Dr Katta Vani
Kalinga Institute of Medical Sciences
研究点 (1)
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